NCT00956735

Brief Summary

This study is investigating the effects of three different diets, including a diet with pistachios, on cardiovascular disease risk markers in people with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

3.6 years

First QC Date

August 10, 2009

Last Update Submit

December 13, 2013

Conditions

Cardiovascular DiseaseType 2 Diabetes

Keywords

Cardiovascular DiseaseType II DiabetesNutritionPistachiosCardiovascular disease risk factors in adults with Type II diabetes

Outcome Measures

Primary Outcomes (3)

  • Cardiovascular responses to stress

    End of each diet period

  • Insulin sensitivity and resistance

    End of each diet period

  • Lipids and lipoproteins

    End of each diet period

Secondary Outcomes (2)

  • Vascular endothelial function

    End of each diet period

  • Mood and perceived stress

    End of each diet period

Study Arms (2)

Pistachio Diet

EXPERIMENTAL

Incorporates 3.0 oz (2 servings) of pistachios into a daily diet

Other: Pistachio

Non-Pistachio

NO INTERVENTION

Does not incorporate pistachios into a daily diet

Interventions

PistachioOTHER

3.0 oz (2 servings) of roasted and salted or unsalted pistachios

Pistachio Diet

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy, nonsmoking adults, aged 30-75 years (women must be post-menopausal)
  • Diagnosed with Type 2 diabetes

You may not qualify if:

  • Insulin, more than one blood pressure lowering medication, daily aspirin, NSAID therapy, oral steroids within the last 6 weeks, oral contraceptives, and hormone replacement therapy
  • Chronic disease such as cardiovascular disease or any complications of diabetes (retinopathy, neuropathy, etc).
  • Allergies or aversions to pistachios
  • Unwillingness to consume all foods provided and no other meals or snacks for the 10 weeks of diet intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University - General Clinical Research Center

University Park, Pennsylvania, 16802-6501, United States

Location

Related Publications (3)

  • Gebauer SK, West SG, Kay CD, Alaupovic P, Bagshaw D, Kris-Etherton PM. Effects of pistachios on cardiovascular disease risk factors and potential mechanisms of action: a dose-response study. Am J Clin Nutr. 2008 Sep;88(3):651-9. doi: 10.1093/ajcn/88.3.651.

    PMID: 18779280BACKGROUND

  • Sauder KA, Pokorney PE, McCrea CE, Ulbrecht JS, Kris-Etherton PM, West SG. Noninvasive assessment of hemodynamics: a comparative analysis of fingertip pulse contour analysis and impedance cardiography. Blood Press Monit. 2015 Aug;20(4):209-14. doi: 10.1097/MBP.0000000000000118.

    PMID: 25815738DERIVED

  • Sauder KA, McCrea CE, Ulbrecht JS, Kris-Etherton PM, West SG. Pistachio nut consumption modifies systemic hemodynamics, increases heart rate variability, and reduces ambulatory blood pressure in well-controlled type 2 diabetes: a randomized trial. J Am Heart Assoc. 2014 Jun 30;3(4):e000873. doi: 10.1161/JAHA.114.000873.

    PMID: 24980134DERIVED

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sheila G. West, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 11, 2009

Study Start

August 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 16, 2013

Record last verified: 2013-12

Locations

US(1)